Novartis nabs early breast cancer nod for CDK4/6 inhibitor

Novartis’ CDK4/6 inhibitor, in combination with endocrine therapy, has been granted Therapeutic Goods Administration (TGA) registration for the adjuvant treatment of patients with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, including those with high-risk node-negative disease. Previously, Kisqali (ribociclib) was solely indicated for metastatic HR+/HER2- breast cancer.

The TGA approval follows a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2024 and is supported by data from the NATALEE trial – a global phase 3 study conducted across 24 Australian sites.

Results showed an invasive disease-free survival rate of 90.4% with Kisqali plus endocrine therapy, compared to 87.1% with endocrine therapy alone (p=0.003). Kisqali’s addition to endocrine therapy also lowered the risk of disease recurrence or death by 25.1% compared with monotherapy in stage II and III early breast cancer.

Dr Sally Baron-Hay, medical oncologist at GenesisCare and Australian investigator for the NATALEE trial, emphasised, “In Australia, the majority of breast cancer cases are diagnosed in the early stages. Although these patients often have better outcomes due to treatment advances, the fact remains, patients with early breast cancer are at risk of their cancer recurring, regardless of nodal involvement.”

She further explained, “Research and clinical experience show that about one-third of those with stage II disease and more than half of those with stage III disease, will have a recurrence. Thirty percent (30%) of those will unfortunately progress to advanced disease, where only three in 10 survive for five years. This TGA registration of Kisqali is a step towards giving hope to all Australians diagnosed with the most common type of early breast cancer.”

The approval coincides with Project Shirley, an Australian-first research initiative on early breast cancer diagnosis, with findings presented at the recent St. Gallen International Breast Cancer Conference. Led by Inherited Cancers Australia with Novartis funding, the study surveyed over 100 patients, 86% with early-stage HR+/HER2- disease.

Project Shirley revealed the pervasive fear of recurrence, with 90% of respondents citing it as their greatest concern. Findings shared at the Early Breast Cancer Awareness event in Parliament House in November 2024 – co-chaired by Senator Deborah O’Neill and Senator Michaelia Cash – highlighted a major challenge: one in two respondents felt that the perception of early breast cancer as the ‘good’ cancer prevented them from openly discussing their fears and challenges.

Additionally, while 70% of patients recalled discussing recurrence with their healthcare professionals, only 28% felt they truly understood it. Most patients were also open to treatments that could reduce recurrence risk, even if the risk was small.

Matt Zeller, Novartis Country President for Australia and New Zealand, stated “We join the national call for zero deaths from this disease in Australia. By building on the existing role of Kisqali in treatment of metastatic breast cancer patients, we hope to help even more patients, including those diagnosed with the most common type of early breast cancer – HR+/HER2- – who are at high risk of recurrence.

“We will continue working together with all stakeholders to enable consistent, timely and equitable access for all patients who can benefit from Kisqali.”

Despite a 40% reduction in breast cancer mortality over the past three decades in Australia, the incidence has surged by 113% since 1994 – from 9,827 new cases a year in 1994 to over 21,000 new cases a year in 2024 – underscoring the ongoing public health challenge posed by this disease.

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